Last updated 4 days ago
Phase 1a/1b First-in-Human Study of BG-C9074 Alone and in Combination With Tislelizumab in Participants With Advanced Solid Tumors
227 patients around the world
Available in Brazil, United States
BeiGene
1Research sites
227Patients around the world
This study is for people with
Solid tumors
Requirements for the patient
From 18 Years
All Gender
Medical requirements
- Able to provide a signed and dated written informed consent prior to any study-specific procedures, sampling, or data collection.Eastern Cooperative Oncology Group (ECOG) Performance Status ≤ 1.Participants with selected histologically or cytologically confirmed advanced, metastatic, and unresectable solid tumors who have been previously treated.≥ 1 measurable lesion per Response Evaluation Criteria in Solid Tumors, version 1.1 (RECIST v1.1).Able to provide an archived tumor tissue sample.Adequate bone marrow and organ function.Females of childbearing potential must be willing to use a highly effective method of birth control for the duration of the study, and for ≥ 7 months after the last dose of study drug(s).Nonsterile males must be willing to use a highly effective method of birth control for the duration of the study treatment period and for ≥ 4 months after the last dose of study drug(s).
- Prior treatment with a B7 homolog 4 (B7H4)-targeting antibody-drug conjugate (ADC) or an ADC with a topoisomerase 1 inhibitor (TOP1i) payload.Active leptomeningeal disease or uncontrolled, untreated brain metastasis.Any malignancy ≤ 2 years before the first dose of study treatment(s) except for the specific cancer under investigation in this study and any locally recurring cancer that has been treated with curative intent (eg, resected basal or squamous cell skin cancer, superficial bladder cancer, or carcinoma in situ of the cervix or breast).History of interstitial lung disease, ≥ Grade 2 noninfectious pneumonitis, oxygen saturation at rest < 92%, or requirement for supplemental oxygen (including intermittent use) at baseline.Uncontrolled diabetes.Infection (including tuberculosis infection) requiring systemic (oral or intravenous) antibacterial, antifungal, or antiviral therapy ≤ 14 days before the first dose of study treatment(s).
Sites
Instituto do Câncer do Estado de São Paulo "Octavio Frias de Oliveira" - ICESP
SponsorBeiGene
Study typeInterventional
Conditions
Solid tumors
Requirements
From 18 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT06233942
